Reported Dec 26, 2012 · Terminated
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 700 Harris St Ste 109 · Charlottesville, VA · 22903-4584
Is this the product you have?
- Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
- Lot codes and dates
Lot L33Serial numbers H64Y009-GMH64A056H640576H600272H640784H640774H640764H600603H640547
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
This product could cause temporary or reversible health problems — stop using it.
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